Anirban Mukherjee

• Investigating & understanding key business issues, existing business models and the data flow and provided clear and timely analysis/recommendations and improvements.
• Regularly interacting with the customer business team (includes scientists, systems engineers, requirement engineers, architects, designers, developers, testers, project managers, product owners etc.) through stakeholder meeting, workshop, strategic meet up, scrum escalation meeting, requirement review meeting, JAD, Catch up and 1-0-1 pairing to understand stakeholder needs and transform these needs to simplified functional and non-functional business requirements.
• Supporting operations and related processes. Gap analysis and process optimization and implementation of improvements.
• Develop KPIs such as, value add, resource spent / time, dollar spent / time, time to delivery, time to resolve, planned vs. actual delivery using SMART criteria etc.
• Using statistical techniques (quality tools and SPC) to analyze variation and risk.
• SME advising for the development of Medical Device (Audiological) software for Cochlear Implant and Hearing aids.
• Creating and defining algorithms and statistical and mathematical calculations for acoustic strategy, mapping, stimuli response and different telemetry etc.
• Working as a liaison across Business owners and the Delivery team to facilitate successful execution of deliverables.
• Requirement elucidation, gap analysis, interface analysis, challenge analysis
• Developing User Stories, SRS, Use Cases, Clinical Parameters, and Business Rules
• Defining process flows and work flows, wireframes, models, prototypes, activity diagrams, sequence diagrams
• Managing product risk, creating risk responses (CAPA), conducting Hazard Analysis, authoring different Risk Management files and reports.
• Handling and resolving CR (Change Request) and non-conformants are according to the industry’s best practices.
• Reviewing test plans to ensure that all requirements are addressed by the test procedures. Exploratory testing to gain further insight on the system to help VnV to develop effective test plan.
• Conducting Quality Reviews, Documentation Reviews including SOP reviews. Designing and monitor test cases, user scenarios, test plans etc. Exploratory testing to gain insight on the system and to assist in developing effective test plan.
• Train and direct the team for domain.
• Enhancing Healthcare and Medical Device domain competency and providing regulatory compliance guidance.

• Heading the clinical data management group. Establishing a Healthcare Pharma vertical in the organization.
• Engaged in Operational Excellence; lift man step to process transformation and introducing business value articulation
• Understanding the pain areas and developing one stop, client specific, enterprise class solutions.
• Providing Solution Design and Proposal, Requirement Analysis, Risks Management Plan, Gap Analysis, Regulatory Compliance guidance, Pseudo Code, Logical Architecture and Mathematical Design, SME testing and computer system validation etc.
• Managing stakeholders, performance management, metrics reporting, invoice, escalation, handling SLA and service metrics, employee idea process etc.
• Defining product lines for Healthcare systems such as M.U (Meaningful Use) compliant Electronic Heath Record Systems (EHR) and Electronic Medical Records systems (EMR), HCP aggregate spend data and reporting system in accordance with evolving Federal and State requirements (DC and ME).
• Designing Medical Device software such as vital signs monitors and Clinical Trial systems such as CTMS, CDMS, EDC, and CDAR and Laboratory Information Management system (LIMS).
• Providing compliancy guidance including 21CFR (Part 11, Part820, Part 807, Part 814 etc.), 520(k)/PMA process, GDP, GLP and GMP, EDI transactions and code sets, HIPAA, PHI, PPACA, HCP(O) Aggregate Spend, HITECH, CDISC (SDTM and ODM), ISO 9001, ISO 14971, ISO 13485, IEC 62304
• Building long term key customer relation, identification of champions, generating future scopes.
• Defining business scopes and preparing BRD for internal products.
• Training internal stakeholders on Sunshine Legislation, FDA guidance’s, GxPs, CFRs, ISOs
• Representing the organization in international seminars and conferences, accepting positions or offices (whether for profit or otherwise) in any trust, firm, society, club, company, corporation or the like on behalf of the organization and training.

• Facilitated Functional decomposition of requirements, interface analysis, functional and non-functional requirement review and analysis at various interfaces of project development, documenting requirement risks, analyzing challenges and risks in eliciting requirements.
• Analyzed business rules, assessing the client, modeling data,  analyzing decisions, analyzing documents. Creating organizational models, scope models and mind maps.
• Designing risk strategies and creating risk responses.
• Developing domain specific use cases, business rules, class models and conducting quality assurance testing of measures modules.
• Train and direct the team for domain specific requirements. Work with developers to create prototypes and review with business users. Assisted the Business Development team in developing scope, capabilities etc. in clinical trial domain. 
• Reviewed and audited system compliancy with CFR21 regulations  and ICH guidelines. Converted existing raw data into CDISC (SDTM) standards and reviewed SOPs and CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in the protocol.
• Directing the development of CDMS software for various neurocognitive drug trials. Estimation of CTMS projects, analyzing business rules, assessing the client, modeling data, analyzing decisions, analyzing documents. Creating organizational models, scope models and mind maps.
• Architected the orchestration framework and the logical design for different neuro-cognitive and neuro-motor clinical trial data management software.
• Created complete scientific algorithms, statistical and mathematical calculations for different modules for a big CDMS system and helped project architects in developing compliant process definition and flows. Rendered business knowledge and scientific concepts related to clinical software development. 
• Creating and defining algorithms and statistical and mathematical calculations for different measure modules such as subject mapping, response randomization, stimuli sequencing etc.

• Managing Enterprise solutions for hospitals that connects different client data systems such as EMR and EHR.
• Implemented HIPAA policies.
• Review and approval for regulatory dossier and documents.

• Taught graduate (MS) and undergraduate (BS) level Pharmacodynamics, Pharmacovigilance, Bioinformatics, Genetics and Molecular Cell Biology
• Involved in making and grading of quizzes, projects, and exams, group reviews etc.
• Managed the laboratory resources, assisted in GTA weekly meetings and seminars
• Conducted various student projects and advised for Master’s and Bachelor’s dissertation.

I assisted in projects which were associated with the investigational drugs of oncology segment. I was involved in the processing of data from phase I, II and III of clinical trials and generating TLG’s according to the specifications. I was also involved in developing and management of regulatory submission documents to FDA and other controlling agencies.

Each cell communicates with another cell or environment by a process called signal transduction. This is the key for many pathways of expression of life.

The signaling in cell occurs by the help of surface signal receptor proteins. GPCRs are one of such proteins. GPCRs work in “lock and key” relation with specific ligand molecules. Those ligands bind to specific facets of GPCRs and this binding creates structural changes in the GPCR protein which initiates arrays of different pathways inside the cell. One of these pathways results in pancreatic cancer. We have taken human pancreatic cell lines and modified the GPCRs structure by introducing nanobots that bound to specific portions of the protein and changed structure of the latter. These structural changes resulted in decreasing the cell proliferative effect.

I was involved in the extraction and analysis of clinical trials data, generation of graphs, listings, and reports that supported the statistical and medical writing.

• Managing project for one of the earliest e-commerce application (DreamHobbys).